NCT06006871

Effectiveness of the Serious Video Game MOON in Emotional Regulation in ADHD

The Secret Trail of Moon (MOON): a Personalized Treatment Video Game for Children and Adolescents With ADHD Based on Cognitive Training and Self-regulation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Puerta de Hierro University Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Introduction: Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurodevelopmental disorder in childhood and adolescence (5%) with associated difficulties and worse prognosis if undetected. Multimodal treatment is the treatment of choice, however, sometimes it can be insufficient or have some drawbacks. Objective: To demonstrate the effectiveness of cognitive training through the video game 'The Secret Trail of Moon' (MOON) in improving emotional regulation of ADHD in people aged 7 to 18 years. Hypotheses: H1: ADHD patients using MOON improve their emotional regulation more than the control group; H2: ADHD patients using MOON improve in symptomatology with respect to the control group; H3: ADHD patients using MOON improve their cognitive abilities than the control group; H4: ADHD patients using MOON improve in academic performance with respect to the control group; H5: The change of platform (face-to-face, online) does not entail differences in emotional regulation; H6: There are no side effects associated with the video game. Methods: Design: prospective, unicenter, randomized, unblinded, PRE-POST intervention study. Randomization of the groups (MOON vs. Control) will be performed by electronic CRD. The MOON intervention will be performed 2 times/week for 10 weeks (30 minutes/session). The first five weeks (10 sessions) will be conducted face-to-face; the remaining weeks will be conducted online at the participants' home. Sample: 152 patients with a clinical diagnosis of ADHD (CGI between 3 and 6) with pharmacological treatment. Evaluation: a data collection notebook will be used to obtain demographic and clinical data. The data will be recorded with electronic CRD (REDCap). Measures to answer the hypotheses will be made through clinical scales for parents and objective tests of cognitive abilities in patients. Additional information on academic performance will be collected. Statistical power analysis: The study has a power greater than 80% to detect differences. Statistical analysis: Classical statistics: T student, 2-factor ANOVA and Mann Whitney analyses will be performed according to the characteristics of each variable. Ethics: The study was approved by the Research Ethics Committee of the Hospital Universitario Puerta de Hierro on December 14th, 2022. The authorization of the Spanish Agency of Medicines and Health Products was February 14th, 2023. Informed consent will be requested from legal guardians and minors protecting their personal data to the provisions of the Organic Law 3/2018 of 5 December, on Personal Data Protection and guarantee of digital rights.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
BEHAVIORAL	The Secret Trail of Moon (MOON): Cognitive training with Serious Video Game	Patients are pharmacologically stable and receive a cognitive intervention with our videogame twice a week in the hospital (10 sessions) and twice a week in their home with a computer video game (other 10 sessions).
DRUG	Usual treatment for ADHD	All patients continue with their stable pharmacological treatment and do not receive any additional cognitive intervention.

Timeline

• Start date: 2023-05-09
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2023-08-23
• Last updated: 2024-02-13

Locations

1 site across 1 country: Spain